According to Meticulous Research® the global biopharmaceutical processing equipment and consumables market is expected to reach USD 70.84 billion by 2029 from an estimated USD 35.76 billion in 2022, at a CAGR of 10.3% during the forecast period 2022–2029. The growth of this market is mainly attributed to the global initiatives supporting the adoption of biopharmaceuticals, capacity expansions of biopharmaceutical plants, and the growing adoption of single-use bioprocessing equipment and consumables. Moreover, emerging economies, shift towards bioprocessing 4.0, and rising adoption of personalized medicines offer significant opportunities for market growth.
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So far, the biopharmaceutical processing industry has been dominated by stainless-steel/reusable equipment. Most of the biopharmaceutical manufacturing plants have stainless-steel bioreactors, mixers, and bioprocessing vessels. However, in the last few years, this trend has been shifting towards single-use/disposable equipment. This is attributed to various advantages of this equipment over conventional stainless-steel equipment.
Single-use technologies have gained significant traction in bioprocessing over the last few years. The adoption of single-use technologies is rising due to several advantages, such as a reduction in manufacturing costs (by eliminating cleaning and cleaning validation steps). Besides reducing the time and labor required, single-use technologies also help reduce capital costs and energy consumption, thereby improving efficiency. Although single-use systems generate waste from incinerating and discarding plastic materials, they still leave a smaller carbon footprint than permanent steel systems. The carbon dioxide released after generating steam for water for injection (WFI) cleaning and the steam-in-place sterilization of stainless-steel vessels, piping, and other hardware are far more than the carbon dioxide produced from the manufacture and disposal of plastic single-use systems. Thus, the usage of WFI, steam, and cleaning agents is reduced significantly by incorporating single-use platforms.
Contract manufacturers are among the early adopters of single-use technologies, owing to their ability to turn around manufacturing operations quickly. Single-use technologies ensure flexibility to respond quickly and efficiently as per the changing needs in the operations. Advantages of single-use facilities like safety, efficiency, reduced production time are further driving the adoption of single-use technologies. The use of presterilized single-use systems reduces the risk of cross-contamination, thereby helping companies avoid costly downtime and material waste. Single-use solutions are ergonomically designed to hold integrated single-use flow paths for faster set-up and reduced space requirements. This reduces the time and related costs spent on preparation, set-up, validation, and documentation.
The capital expenditure on building single-use plants is usually 60–70% lower than expenditure on building stainless steel plants, and the physical footprint is 30% smaller, further saving 90% in water costs and 50–60% in energy costs. Single-use technologies allowing for lower operational costs, smaller factories, and greener processing have encouraged major biopharmaceutical manufacturers to gradually adopt single-use technologies. In August 2019, Pfizer (U.S.) announced an investment of USD 500 million in gene therapy to expand its manufacturing facility, which would include eight single-use bioreactors, each with a 2,000 L capacity.
Further, to meet the growing demand for single-use technologies in the manufacturing of biopharmaceuticals, key market players are launching new products, driving the adoption of single-use technologies. For instance, in September 2019, a biopharmaceutical manufacturing service provider, ABEC (U.S.), announced the launch of a single-use bioreactor to process the working volume of 6,000 L to meet the changing scalability needs of the manufacturers. Other conventional single-use bioreactors could process the working volumes up to 2,000 L. Later, in March 2021, Thermo Fisher Scientific Inc. (U.S.) joined this bandwagon by launching the 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. Additionally, in October 2021, Thermo Fisher Scientific Inc. (U.S.) also launched a new single-use chromatography system, Thermo Scientific HyPeak chromatography system, the first single-use chromatography system for bioprocessing offered by the company for vaccine development and therapeutic protein production.
Thus, biopharmaceutical manufacturers are turning to single-use technologies owing to the advantages such as faster processing times, flexibility with varied batch sizes, and more efficient unit operations. Integrated single-use solutions ensure faster implementation and improved safety, further shortening development and manufacturing time. They are also ideally suited to meet the requirements of CDMOs, owing to the quick turnaround time.
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Mr. Khushal Bombe
Meticulous Market Research Inc.
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